Primary outcomeLeast squares mean· After 6 months of treatment
Height Velocity (Ht-V)
| Group | Value (cm/year) | Spread |
|---|---|---|
| Group A: 12-month GH Treatment | 12.02 | 0.29 |
| Group B: 6-month Untreated + 6-month GH Treatment | 6.87 | 0.43 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
NCTNCT01778023 (opens ClinicalTrials.gov in a new tab)Other idGH-3899Other idU1111-1125-4790Other id2015-002613-30Other id2015
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 54 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
South Korea
- Start
- 17 Jan 2013
- Primary completion
- 17 Dec 2014
- Completion
- 17 Dec 2014
- First posted
- 29 Jan 2013 (estimated)
- Last update posted
- 2 Jun 2017
- Conditions
- Growth Disorder · Idiopathic Short Stature
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201320142015
- Ph 3
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
NCT0177802317 Jan 2013 to 17 Dec 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
Interventions
- somatropinDrug
Arms2
Experimental
hGH:12months treatment
Active comparator
hGH: 6 month un-treatment + 6 month treatment
Primary outcomes1
Outcomes the sponsor listed as primary.
Height Velocity (Ht-V)
Time frame · After 6 months of treatment
Registry description
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
Secondary outcomes(6)
Change in Ht-SDS (Height Standard Deviation Score)
Time frame · After 6 months of treatment.
Registry description
Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.
Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)
Time frame · After 6 months of treatment.
Registry description
IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.
Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)
Time frame · After 6 months of treatment.
Registry description
IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.
Change in Bone Age
Time frame · After 6 months of treatment.
Registry description
Change in bone age from the baseline to 6 months.
Occurrence of Adverse Events
Time frame · Throughout the trial (12 months)
Registry description
AEs were collected throughout the trial in both groups.
Ht-V (Height Velocity)
Time frame · At the first 6 months and the last 6 months in group A
Registry description
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· After 6 months of treatment.
Change in Ht-SDS (Height Standard Deviation Score)
| Group | Value (Standard Deviation Score (SDS)) | Spread |
|---|---|---|
| Group A: 12-month GH Treatment | 0.76 | 0.04 |
| Group B: 6-month Untreated + 6-month GH Treatment | 0.19 | 0.06 |
Secondary outcomeLeast squares mean· After 6 months of treatment.
Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Group A: 12-month GH Treatment | 192.58 | 14.00 |
| Group B: 6-month Untreated + 6-month GH Treatment | 28.03 | 21.81 |
Secondary outcomeLeast squares mean· After 6 months of treatment.
Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)
| Group | Value (mcg/mL) | Spread |
|---|---|---|
| Group A: 12-month GH Treatment | 0.89 | 0.19 |
| Group B: 6-month Untreated + 6-month GH Treatment | 0.22 | 0.30 |
Secondary outcomeMean· After 6 months of treatment.
Change in Bone Age
| Group | Value (years) | Spread |
|---|---|---|
| Group A: 12-month GH Treatment | 0.5 | 0.2 |
| Group B: 6-month Untreated + 6-month GH Treatment | 0.5 | 0.2 |
Secondary outcomeNumber· Throughout the trial (12 months)
Occurrence of Adverse Events
| Group | Value (events) |
|---|---|
| Group A: 12-month GH Treatment | 70 |
| Group B: 6-month Untreated + 6-month GH Treatment | 25 |
Secondary outcomeLeast squares mean· At the first 6 months and the last 6 months in group A
Ht-V (Height Velocity)
| Group | Value (cm/year) |
|---|---|
| Group A: 12-month GH Treatment | 2.80 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group A: 12-month GH TreatmentFor 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. | – | 4 / 36 | 20 / 36 |
| Group B: 6-month Untreated + 6-month GH TreatmentSubjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. | – | 2 / 15 | 10 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
PubMed tag: none · 2020
Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial.
Jung et al. 2020European endocrinologycited by 4
PMID 32595770PMC7308103DOI 10.17925/ee.2020.16.1.54PUB-32595770
Free to read · publisher termsCC BY-NC
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultSafety and Efficacy Evaluation of Human Growth Hormone (GH) Therapy in Patients with Idiopathic Short Stature (ISS) in Korea - a Randomized Controlled Trial; Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko et al.; 028-042-GH-Pediatrics (posters) ENDO meeting 2016, Boston Massachusetts
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 4 Years up to 11 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Pre-pubertal status (males aged from 4 to 11 \[both inclusive\], females aged from 4 to 9 \[both inclusive\]): an absence of breast development in females (Tanner 1 only) and testicular volume below 4 mL in males
* Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
* Height below 3 percentile
* Bone age below or equal to 12 year
* Epiphyses confirmed as open in patients at least 10 years or more of age
Exclusion Criteria:
* Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))
* Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated)
* Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone
* Bone age is advanced over chronological age more than 3 years
* Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia
* Prior history of intracranial hypertension
* Hypertrophic cardiomyopathy
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